66--506-19-1-1030-0026 - Beckman Chemistry BPA Bridge- Ann Arbor

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >$150K VHAPM Part 808.405-6 Limiting Sources Page 2 of 3 Original Date: 08/30/2017 LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-19-AP-0463, 36C250-19-AP-0642 Contracting Activity: Department of Veterans Affairs, VISN 10-506 Medical Center Department of Veterans Affairs, VA Ann Arbor Healthcare System 2215 Fuller Rd. Ann Arbor, Ml 48105 2237# AA- 506-19-1-1030-0026 Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). Order against: FSS Contract Number: __ V797D-70260 ______ Name of Proposed Contractor: Beckman Coulter Inc Street Address: 200 S. Kramer Blvd.,P.O. Box 8000, City, State, Zip: Brea, CA 92822 Phone: 877-888-8643 X 421109 Description of Supplies or Services: BPA for VAAAHS and Toledo CBOC Chemistry analyzer on a cost per test

basis, to provide reagents, supplies, and equipment needed for patient testing for the period 1/1/19 through 7/31/19 or until new contract is in place. Service is also part of the Cost Per Reportable Test Contract# V797P-7090A. (4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; The reagents, supplies, consumables/disposables, calibrators, standards, and controls used are unique to the Beckman Coulter DxC880i chemistry analyzer currently leased by the VA. If another vendor s reagents and supplies are used with this analyzer, the results would be incorrect In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Pathology and Laboratory Medicine Services at VAAAHS and Toledo CBOC requesting an extension BPA for Beckman Chemistry analyzer on a cost per test basis, to provide necessary laboratory testing for patient care. The request to support the acquisition of a new chemistry analyzer for FY19 is in process. To change vendors includes months of work to interface connections, correlation studies between new and old analyzers and between analyzers, analytical measurement range studies, linearity studies, assay sensitivity studies, precision studies, reference range validation studies, etc. New instruments, especially new vendors, include new training in the operation and analysis of specimens, maintenance procedures, troubleshooting procedures, recoding of instruments and tests associated with the College of American Pathologist (CAP) proficiency programs, and writing of new procedures. Quality control programs for new immunoassay analyzer vendors require new processes to be set up to meet various accreditation agencies requirements: The Joint Commission, CAP, Clinical Laboratory Improvement Amendments (CLIA), etc. All the above requirements and tasks involve cost, in dollars, for various test kits to perform these studies, not to mention the months of a medical technologist labor to perform the above studies. No analyzer can be placed on-line until all validation studies, instrument training, and procedure manuals have been written, reviewed, and approved. Every time a new piece of instrumentation enters the laboratory all precautions are made to provide the necessary training on the analyzers to prevent delay in testing and operator errors that could lead to erroneous results. New instrumentation and new vendors increase the odds of errors mostly due to learning the new system. The FSS contract# V797P-70260 includes the use of the DxC880i chemistry analyzer, reagents, supplies, consumables/disposables, calibrators, standards, controls, and maintenance and service coverage. The reagents and supplies used are unique to the Beckman Coulter DxC880i chemistry analyzer currently used by VAAAHS. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: Market research for new chemistry analyzer for FY19 was conducted. This BPA is to continue services until the FY19 order has been completed and awarded. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: This LSJ is to cover the transition period. The transition of Vendors and to a new equipment takes months to validate and correlate before the analyzers are ready to go live.